FDA 510(k)

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

K-Number: K112771 · 2011-10-14

Decision Date2011-10-14

Product CodeDTN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2011-10-14 under 510(k) number K112771. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG?

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG is a medical device that received FDA 510(k) clearance on 2011-10-14. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K112771.

When did BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG receive FDA 510(k) clearance?

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG received FDA 510(k) clearance on 2011-10-14, under 510(k) number K112771.

Who is the listed applicant for BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG?

The FDA product code for BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG is DTN.

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Related Devices (Code: DTN)

K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L.K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mLMedtronic Cardiac Surgery K223361BMR 1900 PHISIOSorin Group Italia S.R.L.K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc.K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F CSorin Group Italia S.R.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.